Sr Medical Writer - Onsite
Employment Type: Full-Time
Industry: Healthcare - Allied Health
Title: Sr Medical Writer
Location : Sandy Springs, GA
Duration: 1 yr with a possible option to come on as a perm employee
WHAT YOU’LL DO:
Purpose of Role
As the company enters into its first human clinical trials, this position will be responsible for all activities and deliverables related to the company regulatory strategy and execution. This is a leader-doer on a small team and requires high initiative and exceptional technical writing skills to prepare, submit, and maintain high quality submissions including IND’s, NDA’s/BLA’s, and amendments for multiple Company’s products.
Overarching Business Priorities:
What we do: Enable the development of best-in-class therapeutics
How we do it:
• Quality – Complete development of the company family of devices for Phase I/II trials
• Speed – Deliver devices needed on time to support the company pipeline objectives
• Value – Build a winning culture (people) and business (processes, capabilities)
- Preparing regulatory submissions including new INDs, safety reports, protocol and information amendments, new investigator amendments, FDA Briefing Documents, IND Annual Reports.
- Facilitates (in coordination with the SVP of Regulatory Affairs) all activities to initiate and execute FDA meetings (primarily Type B and Type C meetings).
- Maintains expert knowledge of relevant regulations, guidance documents, standards and industry precedents, and uses this knowledge to inform the company regulatory strategy and submissions.
- Assembles and leads cross functional working teams (in meetings and 1:1) to build content, templates, and processes to rapidly generate the company submissions.
- With minimal supervision, write and edit clinical documents needed for regulatory purposes (e.g., protocols, study reports, high level summary documents, Investigator Brochures, briefing documents) for submission within established timelines to support the goals of the R&D development team.
- Participates in or leads the electronic compilation and publishing of routine documents, reports, and reg submissions using eCTD publishing tools.
- Utilizes systems and tools for electronic document capture, generation, manipulation, scanning, and quality control.
- Maintain submission correspondence files and other regulatory files in a complete manner.
- May interface with cross-functional teams and or content authors to discuss routine submission preparation and content.
- Serves as the Regulatory Affairs representative to assess and approve product & process changes through change control.
EDUCATION AND QUALIFICATIONS:
- BS or MS in life sciences or health related field with strong scientific knowledge, technical background and a minimum of 5 years relevant industry experience.
- Experience in medical and/or technical writing required, preferably as lead author of device clinical trials and/or as primary author of regulatory documents.
- Strong external network of regulatory experts and/or consultants preferred.
- Clinical knowledge and ability to write clinical protocols a plus.
- Successful experiences in medical device and/or combination product regulatory submissions and FDA interactions a plus.
- Familiarity with diagnostics and imaging technologies a plus.
- Excellent verbal and written communication skills and interpersonal skills are required. Communicates proactively and effectively within all levels of the organization.
- Proficiency in Microsoft Word, Excel, and PowerPoint required and familiarity with electronic regulatory submissions process a plus.
- Ability to function well as a team player, and get things done in a lean, fast paced and dynamic start up environment. Demonstrated success in rapidly learning new technologies and/or situations. Self-aware of strengths and weaknesses and takes initiative to learn continuously.
- Ability to think strategically, have excellent organization skills and ability to work on several projects with tight timelines is required.
- Proven ability to work independently, meet deadlines and be results-oriented.
- Ability to travel up to 25% of working hours (peaks during certain periods) but on average is expected to be less than 10%, with potential for more travel for specific projects.
- High integrity and takes compliance seriously. Experience and knowledge of regulatory compliance and auditing processes.
- Presentation skills – able to build concise summaries or presentations with clear analysis, options, and recommendations for Sr. Leadership.
- Strong interpersonal skills and a team player who continually demonstrates strong problem solving and conflict resolution skills
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